The environment of the neonatal intensive care unit (NICU) is structured to save the lives of premature babies. While the strategies used in the NICU are lifesaving and necessary, these strategies produce ancillary risks.
Infants in the NICU—even well preemies who are only underweight—are at risk of developmental delay, learning disabilities and sensory processing disorders. A full nine-month gestation provides improved neuromotor development compared to the reduced gestation period of infants born prematurely. In essence, the neuronal pathways of the brain simply do not develop the same as they would in the comfort of the mother's womb. Research shows that if pain and stress are decreased in the preterm infant, brain development is improved. Pain and stress can be diminished through positioning and calming. For instance, a clinician may place a hand on the head and a hand on the body to comfort and gently confine the infant. Though this is calming and helps develop coping skills, the clinician in the busy NICU setting cannot maintain such a time-intensive calming means for long periods.
Research shows that therapeutic positioning and developmental support have positive effects on functional outcomes of NICU graduates and that a lack of attention to developmental positioning can lead to fine and gross motor delays, developmental delays, and head shape deformities. Achieving the best practices in positioning, though recognized as important, is not easy with the currently available products. Positioning of the infant should include support with boundaries leading to symmetrical posture and decreased stress, rotation of the infant into different positions to promote head shaping and motor development, and support to prevent the infant from sliding downward in the crib that occurs due to the elevation of the head of the crib to reduce reflux that is prevalent in premature babies.
Many and numerous devices have been developed to attempt to provide assistance in positioning an infant or in preventing/correcting head shape deformities. One category of these conventional positioning devices provides support for an infant's head through a preformed head-shaped or c-shaped head support, which includes the following: the formed pillow of U.S. Pat. No. 8,332,978 issued to Warnock; the head-shaped form of U.S. Pat. No. 8,590,536 and of U.S. Pat. No. 8,074,312 that are both issued to Tullous; the Bobkids™ baby head rest support of cotton and memory foam; the wedge-shaped pillow of U.S. Pat. No. 8,281,435 issued to Kent; the Mimos® Air Spacer Pillow; the cranial suspension apparatus to prevent positional plagiocephaly of U.S. Pat. No. 6,052,849 issued to Dixon; the oval pillow with a central depression of US Patent Publication No. 2010/0180381 filed by Law; the oval-shaped pillow with a center opening of U.S. Pat. No. 8,069,856 issued to Kell; the doughnut-shaped and gel-filled pillow of U.S. Pat. No. 6,052,850 issued to Salido; the “Inflatable Neck Pillow” of U.S. Design Pat. No. 322,380 issued to El-Asir; the oblong formed shape with a center “form fit” of U.S. Pat. No. 7,322,062 issued to Matthews; the “Orthopedic Pillow” of U.S. Design Pat. No. 416,745 issued to Noyes, the U-shaped head receiver of U.S. Pat. No. 7,698,763 issued to Warnock; and the “Preformed Shape Headrest” of U.S. Pat. No. 6,536,058 issued to Chang. Another set of devices provide both a head and a body support, which include the following: the support for use in a car seat of U.S. Pat. No. 8,419,128 issued to Leach; a “Cushion for Baby Chair” disclosed in U.S. Pat. No. 7,806,471 issued to Nishimoto of Combi Corporation; and EP Patent No. EP1665958A1 filed by Kassai. But in all of these patents, publications and products, the head support is formed and is not reconfigurable to fit the size, shape and variations in position needs of a particular baby and so is limited in usefulness. It does not provide body support with boundaries, does not facilitate rotation of the infant into different positions, does not prevent the infant from sliding downward in the crib, and is limited in its effectiveness to prevent or treat head shape deformities. In the three patents that disclose an additional lower body support, the support is provided only along the exterior of the legs and cannot be repositioned to below the infant, such as to keep the infant from sliding down in the crib. Additionally, these conventional positioning devices provide, at most, limited support with boundaries.
Some other patents disclose pillows that incorporate a hand-shaped element, presumably based on the idea that human hands are comforting to an infant. These include U.S. Pat. No. 4,790,042 issued to Reich that discloses a baby comforter with side arms with attached hands. The side arms can be wrapped around the infant with the hands joined to form a restraint harness. Though the arms can be positioned around the infant, the fixed attachment to the comforter restricts the placement of the arms to a single location, so does not provide for repositioning of an infant, for preventing an infant from sliding downward in a crib, for support with boundaries, or for preventing or correcting head shape deformities. U.S. Design Pat. No. 370,585 to Faithful discloses a single elongated cylinder (representational of arms) with attached hands capable of forming an oval cushion. Though the use is not disclosed, it appears an infant could be positioned within the oval that is formed, but no repositioning assistance, support with boundaries, or prevention/correction of head shape formation could be provided due to the limitation of the single type of formed oval. US Patent Publications No. 2008/0289109 and No. 2003/0226190 filed by Jackson both disclose a pillow imitating a human hand that can be positioned onto a baby, thereby emulating the placement of a human hand onto the baby. While a hand shape may potentially provide comfort and/or calming and/or may by aesthetically appealing or provide emotional comfort to parents, it provides only meager repositioning possibilities or prevention of slipping downward in the crib; it provides no support with boundaries and no prevention/correction of head shape formation due to the limitations inherent in the hand structure.
U.S. Pat. No. 6,161,239 issued to Grazel discloses an elongated sleeve containing polymeric pellets for positioning an infant in a stabilized, simulated fetal position. Though the one-piece construction of the sleeve is stated as an advantage, it is also limiting in the number and types of positions that are enabled, in the provision of support with boundaries, and in the prevention of downward slipping of the infant. Additionally, to allow the sleeve-like device to be bent into the desired position, the fill density of the pellets per volume must be prescribed and must be sufficiently low to provide for the manual bending, as there is no mechanism to facilitate bending beyond reducing the number of pellets within the device.
An additional positioning aid is found in the shaped pillow product that holds or supports the body of the child disclosed in U.S. Pat. No. 7,000,275, which is issued to Brown and assigned to The Boppy Company. This pillow also does not provide support with boundaries suitable for use in an NICU and only aids in retaining the infant in a single position and is of very limited value in rotation through multiple positions because of its fixed shape.
Thus one or more of the numerous currently available products, disclosed inventions, or even the commonly used makeshift rolled towels or sheets (repurposed for positioning) may be used to at least partially meet some of the needs of an infant in NICU. However, a more efficient and effective system is needed (1.) that meets the goal of positioning the infant in flexion, containment, alignment, and comfort while allowing the infant some movement against boundaries; (2.) that can be used both in the isolette (incubator) and later when the infant is moved to the open crib; and (3.) that prevents the infant from slipping downward in the crib or isolette.
Furthermore, infants in the NICU often develop positional head deformities as a result of their NICU stay. Scaphocephaly, in which the head is disproportionately long and narrow, is most often seen in the NICU because premature babies do not breathe as well on their backs. Therefore, these infants are often positioned either on their side or stomach when in the isolette, resulting in a long narrow head shape. Plagiocephaly, in which one side of the head is flattened and the head appears “oblique” in shape, is also seen to a lesser degree. This is often a result of the infant having a preferential head turn. It is estimated that up to 85% of infants have a preferential head turn, and often the preference is to turn the head to the right. It is suspected this is due to both caregiving practices and the way the infant is positioned in the womb prior to delivery. The statistics are wide ranging but it is estimated that up to 47% of babies have a head shape deformity and nearly 20% of infants born prematurely will have a severe head shape deformity.
Even full-term infants are at risk of deformational plagiocephaly. After the 1992 recommendation by the American Academy of Pediatrics that all infants sleep on their backs to prevent sudden infant death syndrome (SIDS), plagiocephaly increased dramatically in frequency. Studies have shown that currently nearly half of all infants demonstrate some degree of plagiocephaly due to this preferential positioning of the head on a firm, hard mattress.
Once the infant reaches about six to twelve months of age, the bones in the head harden and the head shape deformity can only be corrected with an orthotic helmet. The helmet, which can cost up to several thousand dollars, is not always covered by insurance and may not provide a satisfactory result. Therefore, a system that prevents head shape deformity and/or corrects the problem at a very young age would be very desirable.
Accordingly, there is a need for a system and method of use that can be optionally used for improved infant positioning (including rotating an infant through multiple advantageous positions providing flexion, containment, alignment, movement against boundaries), to promote calming an infant, and to prevent and/or correct positional head deformities.